Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Proteus Digital Health, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Self-reported diagnosis of Type 2 Diabetes Mellitus within the past 2-12 months
Hemoglobin A1c ≥7.5 and ≤11, obtained with the point-of-care HbA1c diagnostic device during the enrollment visit
Self-reported current use of metformin for Type 2 diabetes
Male or female ≥ 18
Outpatient
Self-reported capacity to perform "moderate" exercise, as specified by in the 2010 joint American College of Sports Medicine/American Diabetes Association guidelines
Designation of one caregiver to be involved in the study for its entire duration. A caregiver can be a relative, friend, or trained or untrained hired individual.
Self-reported mobile phone reception at home and/or at work
Willingness to adhere to study procedures, including troubleshooting of the Raisin System by a third-party if needed. The third party will be blinded to any personal subject identifiers.
Capacity to read and speak English proficiently, as judged by the investigator during the screening interview
Capacity to understand the instructions for the study, as judged by the investigator during the screening interview
You may not be if
Self-reported treatment with metformin for less than 2 months at the time of screening
Self-reported adverse reaction to metformin (e.g., ongoing nausea, vomiting, bloating, diarrhea) or to other concomitant medications being administered at the time of screening
Self-reported use of injectable hypoglycemic agents, such as insulin, exenatide, liraglutide or pramlintide
Physical or medical condition that could prevent safe participation in moderate levels of physical activity, as surveyed by the Physical Activity Readiness Questionnaire (PAR-Q) and interpreted by the investigator
Inability to use a mobile phone (e.g., to find icons or to open and to read a SMS), or inability to operate the approved glucometer that will be provided for use in the study
Self-reported current (i.e., in the last 12 months) alcohol or drug abuse (including, but not limited, to use of marijuana)
Positive urine pregnancy test for women
Women of child bearing potential who are not using a medically accepted means of contraception. Accepted means of contraception include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy
Self-reported history of myocardial infarction within past 60 days
Self-reported history of cerebral vascular accident within past 60 days
Self-reported history of skin sensitivity to adhesive medical tape or metals
Self-reported history of acute or chronic dermatitis, excluding atopic dermatitis
Self-reported allergies that could preclude safe participation in the study
Current participation in another clinical study, or participation in a clinical study in the past 30 days during which an investigational device or drug was used
Any condition that, in the investigator's opinion, would preclude the subject's being able to meet all of the protocol requirements, or would compromise the subject's safety during participation in the study
Presence of cognitive impairment, as judged by the investigator during the screening interview
Inability to provide informed consent for any reason
